Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020752
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEPCID RPD FAMOTIDINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
PEPCID RPD FAMOTIDINE 40MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20752lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20752ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20752s000_PecidTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2001 SUPPL-6 Labeling

Label is not available on this site.

06/06/2002 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf
04/25/2001 SUPPL-4 Labeling

Label is not available on this site.

11/27/2000 SUPPL-3 Labeling

Label is not available on this site.

03/18/1999 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf
01/20/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2002 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf
05/28/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20752lbl.pdf

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